For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Primarily responsible for reviewing and approving GMP laboratory data and reports supporting microbiological studies for Celsis ATP Bioluminescence and other Microbial Solutions products. This on-site position will be co-located with laboratory personnel at the Charleston site for fostering a collaborative working relationship with laboratory peers. This position will actively integrate with the Quality and Regulatory Affairs leadership to support upholding a high-quality standard in laboratory data. As a peer and mentor to laboratory staff, this position may also assist with daily tasks of maintaining supply materials, laboratory tidiness activities, and will be continually trained on laboratory processes to maintain understanding during quality review duties.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Is capable of understanding and applying requirements related to Alternative Microbiological Method Validation.
• Is a 100% on site position at this time for fostering a collaborative working relationship with laboratory peers.
• Understands and routinely applies Good Manufacturing Practices (GMP) towards reviewing laboratory data.
• Serves as a final Quality approver on Microbial Applications Lab reports.
• Serves as a Quality approver and collaborative resource for laboratory investigations.
• Has an ongoing understanding of various regulatory regulations as applicable to products tested in the Celsis laboratory.
• Maintain records compliance by adhering to regulatory guidelines set forth by the company and varying agencies.
• Assists with laboratory maintenance activities as appropriate.
• Perform all other related duties as assigned.
• Education : Bachelor’s Degree in a Biological or Chemistry Sciences discipline.
• Experience : At least 2 years working in a GMP-regulated environment.
• Certifications/Licensures: None
• Must be comfortable working collaboratively or individually
• High standards for integrity and quality of work performed
The pay range for this position is $65,000 to $80,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
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